To assess the efficacy of citicoline compared to placebo on functional and cognitive outcome in participants with traumatic brain injury.
- Citicoline (CerAxon®)Drug
Other Names: CDP-choline Intervention Desc: Phosphatidylcholine precursor, membrane stabilizer (cytidyl diphosphocholine)
- Placebo Drug
Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.
Interventional, Treatment, Prospective, Randomized, Placebo Control, Parallel Assignment, Efficacy Study.
Patients will be randomized to either the intervention group or the placebo group. The interventional group will take Citicoline (Phosphatidylcholine precursor, membrane stabilizer) intravenously 1gm BD for 7 days followed by 500 mg BD oral for 2 months. The placebo group will receive Multivitamin IV for 7 days and then orally for 2 months. Then they will be given Modified Rankin test for disability and Glasgow Outcome Score at the end of 90 days.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Survival, rate of recovery, toxicity.|
|Secondary||Modified Rankin test for disability and Glasgow Outcome Score. [Outcome at the end of 90 days].|